Specimen retrieval device

ABSTRACT

A specimen retrieval device includes a tubular body, an inner shaft slidably positioned within a longitudinal bore of the tubular body, and a specimen bag supported on the distal portion of the inner shaft. In embodiments, the tubular body tubular body is formed of a lubricious material. The specimen bag is formed from a pattern and welded by a radiofrequency welder. The specimen bag includes a tail section through which the inner shaft passes, and the tail section may be attached to a handle at a proximal portion of the inner shaft.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.16/432,960, filed Jun. 6, 2019, which claims the benefit of and priorityto U.S. Provisional Patent Application No. 62/717,938, filed Aug. 13,2018, the entire disclosures of each of which are incorporated byreference herein.

TECHNICAL FIELD

The present disclosure relates generally to surgical apparatuses for usein minimally invasive surgical procedures, such as endoscopic and/orlaparoscopic procedures, and more particularly, the present disclosurerelates to a surgical apparatus including a specimen retrieval devicefor collecting body tissue(s) and/or body fluid(s) during theseprocedures.

BACKGROUND

Minimally invasive surgery, such as endoscopic surgery, reduces theinvasiveness of surgical procedures. Endoscopic surgery involves surgerythrough body walls, for example, viewing and/or operating on theovaries, uterus, gall bladder, bowels, kidneys, appendix, etc. There aremany common endoscopic surgical procedures, including arthroscopy,laparoscopy, gastroentroscopy and laryngobronchoscopy, just to name afew. In these procedures, trocars are utilized for creating incisionsthrough which the endoscopic surgery is performed. Trocar tubes orcannula devices are extended into and left in place in the abdominalwall to provide access for endoscopic surgical tools. A camera orendoscope is inserted through a trocar tube to permit the visualinspection and magnification of a body cavity. The surgeon can thenperform diagnostic and/or therapeutic procedures at the surgical sitewith the aid of specialized instrumentation, such as forceps, graspers,cutters, applicators, and the like, which are designed to fit throughadditional cannulas.

When removing certain tissues from the body cavity, for example tumortissue, it is important that the tumor tissue does not come into contactwith healthy or uninvolved tissue. If tumor tissue or tissue parts haveto be removed, they may be introduced into an “extraction bag,” alsoreferred to herein as a “specimen bag,” at the site where the tumor ordiseased tissue has been detached from the surrounding tissue, afterwhich the specimen bag is withdrawn from the body, thereby minimizingcontact of the diseased tissue with healthy tissue.

Improved specimen bags for use in minimally invasive surgical proceduresremain desirable.

SUMMARY

The present disclosure is directed to surgical apparatuses and methodsfor their use in minimally invasive surgery. In embodiments, the presentdisclosure provides a specimen retrieval device including a tubular bodydefining a longitudinal bore, the tubular body having a proximalportion, a distal portion, and a hand grip supported on the proximalportion of the tubular body. The specimen retrieval device also includesan inner shaft having a proximal portion, a distal portion, an actuationhandle supported on the proximal portion of the inner shaft, and asupport member extending from a distal portion of the inner shaft. Thespecimen retrieval device also includes a specimen bag supported on thesupport member at the distal portion of the inner shaft, the specimenbag including an open end, a body, and a tail portion having alongitudinal bore through which the inner shaft passes. The inner shaftis movable in relation to the tubular body from a non-actuated positionin which the specimen bag is positioned in a non-deployed state withinthe longitudinal bore of the tubular body, to an actuated position inwhich the specimen bag is positioned in a deployed state externally ofthe distal portion of the tubular body.

In embodiments, a proximal portion of the tail portion of the specimenbag has a hole, and the actuation handle includes a post which passesthrough the hole at the proximal portion of the tail portion of thespecimen bag.

In some embodiments the post is chamfered.

In other embodiments, the support member includes a pair of resilientfingers which support the specimen bag and open the open end of thespecimen bag in the deployed state.

In some embodiments, the resilient fingers are positioned adjacent theopen end of the specimen bag to open the specimen bag when the specimenretrieval device is in the deployed state.

In embodiments, the tubular body is formed of a lubricious material.

In some embodiments the tubular body is formed of a polymeric materialcombined with a lubricious material.

In other embodiments, the lubricious material includes hydrophilicpolymers, siloxanes, polycarbonates, urethanes, parylenes, orcombinations thereof.

In some embodiments, the lubricious material includes a siloxaneselected from polydimethylsiloxanes, hexamethyldisiloxanes,polyester-modified methylphenyl polysiloxanes, or combinations thereof.

In other embodiments, the tubular body is formed of a combination of asiloxane and a polycarbonate.

In embodiments, the tail of the specimen bag includes a reinforcementtab.

Methods of the present disclosure also include methods for forming thespecimen bag. In embodiments, the method includes cutting a fabric toform a pattern having a body portion and flaps that may be folded andattached to the body portion of the pattern to form a specimen bag. Themethod also includes cutting holes along the periphery of the pattern;placing the pattern on a radiofrequency welder and locating the patternin the proper position with the holes along the periphery of thepattern; folding at least some of the flaps of the pattern and attachingthem to the body portion of the pattern with the radiofrequency welderto form a channel at a mouth of the specimen bag; placing areinforcement tab at a proximal portion of the pattern; and folding aflap at the proximal portion of the pattern and attaching it to the bodyportion of the pattern with the radiofrequency welder to form a tailsection of the specimen bag. The tail section thus includes thereinforcement tab sandwiched between the flap and the body portion ofthe pattern. The method also includes folding a last flap at a distalportion of the pattern and attaching it to the body portion of thepattern with the radiofrequency welder to form a body of the specimenbag.

In some embodiments, the method further includes placing a suture withinthe channel at the mouth of the specimen bag.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed specimen retrieval deviceare described herein below with reference to the drawings, wherein:

FIG. 1 is a side perspective view of an exemplary embodiment of thepresently disclosed specimen retrieval device in a deployed state;

FIG. 2 is an exploded view of the specimen retrieval device shown inFIG. 1;

FIG. 3 is a side view of a pattern suitable for forming a specimen bagof the specimen retrieval device of the present disclosure;

FIG. 4 is a side view of the pattern for forming a specimen bag shown inFIG. 2, showing folding of portions of the pattern to produce featuresof the specimen bag;

FIG. 5 is a side view of the pattern for forming a specimen bag shown inFIG. 3, showing folding of additional portions of the pattern to produceadditional features of the specimen bag;

FIG. 6 is a side view of the pattern for forming a specimen bag shown inFIG. 4, showing folding of additional portions of the pattern to produceadditional features of the specimen bag;

FIG. 7 is an enlarged view of the indicated area of detail shown in FIG.1;

FIG. 8 is an enlarged perspective view of a proximal portion of thespecimen retrieval device shown in FIG. 1 with an actuation handle in anadvanced position;

FIG. 9 is a distal view of the actuation handle of the specimenretrieval device shown in FIG. 8;

FIG. 10 is a top view of the actuation handle and a hand grip of thespecimen retrieval device shown in FIG. 1;

FIG. 11 is a top view of the specimen retrieval device shown in FIG. 1;and

FIG. 12 is a top view of the specimen retrieval device shown in FIG. 11,depicting the withdrawal of the specimen bag into the tubular body ofthe specimen retrieval device.

DETAILED DESCRIPTION OF EMBODIMENTS

The present disclosure provides a specimen retrieval device for use inminimally invasive surgical procedures. As used herein with reference tothe present disclosure, minimally invasive surgical procedures encompasslaparoscopic procedures, arthroscopic procedures, and endoscopicprocedures, and refer to procedures utilizing scopes or similar deviceshaving relatively narrow operating portions capable of insertion througha small incision in the skin.

The aspects of the present disclosure may be modified for use withvarious methods for retrieving tissue specimens during minimallyinvasive surgical procedures, sometimes referred to herein as minimallyinvasive procedures. Examples of minimally invasive procedures include,for example, cholecystectomies, appendectomies, nephrectomies,colectomies, splenectomies, and the like.

The presently disclosed specimen retrieval device will now be describedin detail with reference to the drawings in which like referencenumerals designate identical or corresponding elements in each of theseveral views. In this description, the term “proximal” is usedgenerally to refer to that portion of the device that is closer to aclinician, while the term “distal” is used generally to refer to thatportion of the device that is farther from the clinician. The term“clinician” is used generally to refer to medical personnel includingdoctors, surgeons, nurses, and support personnel.

Referring to FIGS. 1-12, and initially with reference to FIGS. 1 and 2,the specimen retrieval device 10 of the present disclosure includes atubular body 12 having a proximal portion 16 and a distal portion 18,and defining a longitudinal bore 14 that extends between the proximalportion 16 and the distal portion 18. The proximal portion of thetubular body 12 supports a hand grip 15. The specimen retrieval device10 also includes an inner shaft assembly 20 (FIG. 6) including an innershaft 22 slidably positioned within the longitudinal bore 14 of thetubular body 12, an actuation handle 25 secured to a proximal portion 24of the inner shaft 22, and a specimen bag 40 (FIG. 1) supported on adistal portion 26 of the inner shaft 22.

The hand grip 15 on the tubular body 12 may be formed as a unitarycomponent or, as depicted in FIG. 6, as two separate half components 15a, 15 b, that are coupled to one another about the tubular body 12 byone or more suitable coupling methods (e.g., one or more suitableadhesives). In the latter instance, an indent/detent configuration (notshown) may be utilized to facilitate coupling the two separate halfcomponents 15 a, 15 b to one another.

The actuation handle 25 on the inner shaft 22 may likewise be formed asa unitary component or, in embodiments, as depicted in FIG. 6, as twoseparate half components 25 a, 25 b that are coupled to one another byone or more suitable coupling methods (e.g., one or more suitableadhesives).

The specimen bag 40 includes a body 44 having a generally tubular orelongated configuration that is defined by an openable and closableportion (or mouth) 42 and a closed portion 46 (FIG. 1). The closableportion 42 defines an opening 45. In some embodiments, the specimen bag40 includes a tail 48 (FIG. 2) having a neck region 47. Alternatively,other specimen bag configurations are envisioned.

The body 44 of the specimen bag 40 may be made from any suitablebiocompatible material (e.g., nylon, urethane, ripstop nylon or latex)capable of forming a flexible collapsible member, or membrane. Inembodiments, the material from which the specimen bag is made isresilient, antistatic, pyrogen-free, non-toxic, and sterilizable. Thespecimen bag 40 may be opaque or clear. In some embodiments, the body 44of the specimen bag 40 is formed of a nylon material, or combinations ofnylon materials. As described in greater detail below, in someembodiments portions of the specimen bag 40 are made of two differentnylons that are secured together to form areas of the specimen bag 40having high strength. In some embodiments, the first nylon material is a30 denier (“30 D”) polyurethane coated rip-stop nylon; and the secondnylon material is a 1000 denier (“1000 D”) polyurethane coated nylon.

Turning to FIGS. 3-6, methods for forming the specimen bag of thepresent disclosure will be described. In embodiments, the specimen bag40 (FIG. 1) is made using a radio-frequency (“RF”) welding process thatdoes not require additional reinforcement at the seams (e.g., sutures,interface materials, etc.). As depicted in FIGS. 3-6, the fabric used toform the specimen bag 40 of the present disclosure is cut to form apattern 50, with holes 57 along a periphery of the pattern 50. Any meanswithin the purview of those skilled in the art may be used to cut thefabric to form the pattern 50. The holes 57 assist in placement of thepattern 50 on an RF welder (not shown) used to form the specimen bag 40.

Once the pattern 50 has been cut from the fabric, the pattern 50 isplaced onto the radiofrequency (RF) welder and located using the holes57 running along the periphery of the pattern 50 (not shown).

After forming the pattern 50 used to form the specimen bag 40, thepattern 50 has various portions that may be folded to form the specimenbag 40, including flaps 51, 52, 53, 54, 55, and 56 (FIG. 3).

Once positioned on the RF welder, the flaps 51, 52, 53 and 54 are foldedover along lines “B” and “C” (FIG. 3) and welded to the fabric (FIG. 4),to form a channel 43 at the mouth 42 of the specimen bag 40 (FIG. 1).The channel 43 may include a suture therein (not shown), which may beused to close the mouth 42 of the specimen bag 40. The flap 55 may thenbe folded along line “C” (FIGS. 3 and 4) at the proximal portion 59 ofthe pattern 50 to form a tail section 49 of the specimen bag 40 (FIG.4).

As shown in FIG. 2, a reinforcement tab 58 may be placed at the proximalportion 59 of the pattern 50 and flap 55 is folded along line “C” sothat the reinforcement tab 58 is sandwiched between the fabric as theflap 50 is folded over and attached to the body 61 of the pattern 50. Inembodiments, the reinforcement tab 58 is formed of 1000 D nylonsandwiched between the 30 D fabric used to form the pattern 50. Thereinforcement tab 58: adds strength to the 30 D material and also actsas a retention feature to prevent the specimen bag 40 from cinchingduring initial retraction; aids in placement of the specimen bag 40 onthe inner shaft 22 and removal of the specimen bag 40 from the bodyand/or the inner shaft 22 of the specimen retrieval device 10; preventsthe tail 48 from ripping without the need for additional suturereinforcement during retraction; and acts as an indicator of the overalldevice orientation (with respect to location of mouth 42 of the specimenbag 40) for ease of insertion of a tissue specimen into the specimen bag40 (not shown).

Once folded, flaps 51, 52, 53, 54 and 55 are secured by RF welding. Theflap 56 is then folded along line “D” and welded with the RF welder toform the body 44 of the specimen bag 40 (FIG. 5).

The pattern 50 includes a through-hole 60 on flap 55 that allows the RFwelder to secure multiple layers of fabric together (not shown),including welding the flap 56 to the pattern 50 through the through-hole60 on flap 55 at the neck region 47 of the tail 48. This reinforces theneck region 47, which will experience loads during specimen removal.

The radio-frequency (RF) welding process does not necessitate additionalreinforcement via suturing and/or interface materials to bolster the bagseams (found in commercially available products). This combination ofthe RF welding process and the selection of materials used to form thespecimen bag 40 creates a strong, leak proof bag for specimencontainment and removal.

As shown in FIG. 6, the specimen bag 40 has a body 44 and a tail 48 thatthe inner shaft 22 passes through.

As depicted in FIGS. 7-10, in embodiments, the actuation handle 25 atthe proximal portion 24 of the inner shaft 22 has a post 27 forattaching specimen bag 40 to the actuation handle 25 (instead ofcarabiner types of attachments that are used by other commerciallyavailable devices), by placing the post 27 on actuation handle 25through a hole 62 at a proximal portion 49 of the tail 48 of thespecimen bag 40 (FIG. 7). The use of the post and hole configuration forattaching the tail 48 of the specimen bag 40 to the actuation handle 25allows for easy and simple removal of the specimen bag 40 from theactuation handle 25. In addition, the design permits a more ergonomicshape for the actuation handle 25, enhancing the deployment andretraction of the specimen bag 40 from the actuation handle 25.

In embodiments, as depicted in FIGS. 7-10, the post 27 is chamfered,which allows the hole 62 at the tail 48 of the specimen bag 40 to flexover and stay secured to the post 27 until it is ready to be removed.

Referring to FIG. 6, the distal portion 26 of the inner shaft 22 iscoupled to a support member 28 that is configured to support the mouth42 of the specimen bag 40. In embodiments, the support member 28includes a pair of resilient fingers 30, 32 that extend distally fromthe distal portion 26 of the inner shaft 22. In embodiments, theresilient fingers 30, 32 can be integrally formed with the distalportion 26 of the inner shaft 22 such as by molding. Alternatively, aretention pin (not shown) may be used to attach the resilient fingers30, 32 to the distal portion 26 of the inner shaft 22. The resilientfingers 30, 32 are movable from a spaced non-deformed state (not shown)to a deformed state (FIG. 1) to facilitate placement of the specimen bag40 into the tubular body 12.

The resilient fingers 30, 32 return to the non-deformed state when thespecimen bag 40 is deployed from the tubular body 12 to open the opening42 of the specimen bag 40, as described below.

In an assembled configuration, the hand grip 15 and the actuation handle25 can be manipulated to facilitate manipulation of the specimenretrieval device 10 and the sliding of the inner shaft 22 within thetubular body 12. More specifically, the hand grip 15 can be grasped bythe clinician with one hand and the actuation handle 25 can be graspedby the clinician with the other hand to move the inner shaft 22 withinthe tubular body 12.

The tubular body 12 and/or the inner shaft assembly 22 of the presentdisclosure are made of biocompatible materials within the purview ofthose skilled in the art, in embodiments, polymeric materials. Forexample, the tubular body 12 and/or the inner shaft assembly 22 may bemade of polycarbonates or thermoplastic polyurethanes sold under thename PELLETHANE®, which offer flexibility and a wide range of hardness.The tubular body 12 and/or the inner shaft assembly 22, for example, maybe fabricated from PELLETHANE® 2363-80A, PELLETHANE® 2363-90A,PELLETHANE® 2363-55 D, any combination thereof, or any alternativeswithin the purview of those skilled in the art.

In embodiments, the tubular body 12 is made of a polymeric materialcombined with a lubricious material. Examples of suitable lubriciousmaterial include hydrophilic polymers, siloxanes, polycarbonates,urethanes, and/or parylenes, among other lubricious materials within thepurview of those skilled in the art. In embodiments, a siloxane may beused as the lubricious material. Suitable siloxanes include, but are notlimited to, polydimethylsiloxanes, hexamethyldisiloxanes,polyester-modified methylphenyl polysiloxanes, combinations thereof, andthe like. In other embodiments, a combination of a siloxane and apolycarbonate may be used to form the tubular body 12.

For example, in some embodiments, the tubular body is made of a blend ofa polycarbonate with a siloxane, which is extruded into the form of thetubular body. The siloxane improves lubricity for the passage of theinner shaft assembly and the specimen bag through the outer tube todeploy the specimen bag in the patient's body.

In some embodiments, the tubular body 12 and the inner shaft assembly 22are formed of the same material. In other embodiments, the tubular body12 and the inner shaft assembly 22 are formed of different materials.

In embodiments, the mouth 42 of the specimen bag 40 has a pull string 70attached thereto (FIG. 11), as well as resilient fingers 30, 32 attachedthereto. In other embodiments, the resilient fingers 30, 32 and the pullstring 70 may be received in the cuff 43 formed at the mouth 42 of thespecimen bag 40.

In use, the tubular body 12 of the specimen retrieval device 10 can beinserted through an incision (not shown) with the specimen bag 40 furledabout the inner shaft 22 and positioned within the tubular body 12 toposition the specimen bag 40 in a body cavity adjacent a surgical site.When the tubular body 12 is properly positioned, the clinician can gripthe hand grip 15.

The clinician then pushes the actuation handle 25 on the proximalportion 24 of the inner shaft 22 distally in relation to the hand grip15 and the tubular body 12 (not shown), so the distal portion 26 of theinner shaft 22, including the specimen bag 40, exits the distal portion18 of the tubular body 12 (FIG. 1). Once the specimen bag 40 has exitedthe tubular body 12, the resilient fingers 30, 32 (FIG. 4) return totheir non-deformed state, thereby opening the mouth 42 of the specimenbag 40 to ensure the specimen bag 40 is deployed (FIG. 11).

As depicted in FIG. 12, after a tissue specimen (not shown) has beenplaced in the specimen bag 40, the pull string 70 is pulled proximally(indicated by arrows “A” in FIG. 12) to pull the pull string 70proximally, thus cinching the mouth 42 of the specimen bag 40 closingthe opening 42, and withdrawing a portion of the specimen bag 40 intothe inner shaft 12 (indicated by arrow “B” in FIG. 12). As depicted inFIG. 12, the proximal portion 72 of the pull string 70 may be in theform of a loop 74 that may assist in pulling the pull string 70.

Kits of the present disclosure may include both the specimen retrievaldevice described above, as well as trocars, graspers, vacuum sources(tubes), combinations thereof, and the like. In some embodiments, theseadditional devices, such as graspers and/or vacuum sources, may be usedto break up the tissue specimen in the specimen bag prior to removingthe specimen retrieval device from the body cavity.

Once the specimen retrieval device of the present disclosure has beenremoved from the patient's body, any tissue specimen may be removed fromthe specimen bag 40 for further examination and the specimen bag 40 maybe discarded.

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of particular embodiments. Those skilled in the artwill envision other modifications within the scope and spirit of theclaims appended hereto. Additionally, it is envisioned that the elementsand features illustrated or described in connection with one exemplaryembodiment may be combined with the elements and features of anotherwithout departing from the scope of the present disclosure, and thatsuch modifications and variations are also intended to be includedwithin the scope of the present disclosure. Accordingly, the inventionis not to be limited by what has been particularly shown and described,except as indicated by the appended claims.

1-13. (canceled)
 14. A specimen retrieval device comprising: a tubularbody defining a longitudinal bore, the tubular body having a proximalportion, a distal portion, and a hand grip supported on the proximalportion of the tubular body; an inner shaft having a proximal portion, adistal portion, an actuation handle supported on the proximal portion ofthe inner shaft, and a support member extending from the distal portionof the inner shaft; a specimen bag supported on the support member atthe distal portion of the inner shaft, the specimen bag including anopen end, a body, and a tail portion having an enclosed longitudinalbore through which the inner shaft passes, the open end defining a mouthhaving a channel; and a suture within the channel at the mouth of theopen end of the specimen bag, wherein the inner shaft is movable inrelation to the tubular body from a non-actuated position in which thespecimen bag is positioned in a non-deployed state within thelongitudinal bore of the tubular body to an actuated position in whichthe specimen bag is positioned in a deployed state externally of thedistal portion of the tubular body.
 15. The specimen retrieval device ofclaim 14, wherein a proximal portion of the tail portion of the specimenbag has a hole, and the actuation handle includes a post which passesthrough the hole at the proximal portion of the tail portion of thespecimen bag.
 16. The specimen retrieval device of claim 15, wherein thepost is chamfered.
 17. The specimen retrieval device of claim 14,wherein the support member includes a pair of resilient fingers whichsupport the specimen bag and open the open end of the specimen bag inthe deployed state.
 18. The specimen retrieval device of claim 17,wherein the resilient fingers are positioned adjacent the open end ofthe specimen bag to open the specimen bag when the specimen retrievaldevice is in the deployed state.
 19. The specimen retrieval device ofclaim 14, wherein the tubular body is formed of a lubricious material.20. The specimen retrieval device of claim 19, wherein the tubular bodyincludes a polymeric material combined with the lubricious material. 21.The specimen retrieval device of claim 20, wherein the lubriciousmaterial includes hydrophilic polymers, siloxanes, polycarbonates,urethanes, parylenes, or combinations thereof.
 22. The specimenretrieval device of claim 20, wherein the lubricious material includes asiloxane selected from polydimethylsiloxanes, hexamethyldisiloxanes,polyester-modified methylphenyl polysiloxanes, or combinations thereof.23. The specimen retrieval device of claim 20, wherein the tubular bodyis formed of a combination of a siloxane and a polycarbonate.
 24. Thespecimen retrieval device of claim 14, wherein the tail portion of thespecimen bag includes a reinforcement tab.